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TECNIS IOL PCB00 (REF PCB0000320)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 32.0D · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474558502), received between Dec 1, 2016 and Aug 29, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Contamination with Chemical or Other Material1
  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1
  • Visual Disturbances1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 29, 2022Material Fragmentation; Material Fragmentation

    THE SURGERY CENTER REPORTED A MISSING HAPTIC INCIDENT WITH AN INTRAOCULAR LENS (IOL). THROUGH FOLLOW UP WE LEARNED THAT THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THE SURGEON CHOSE TO KEEP THE LENS IMPLANTED AS IT WAS STABLE ENOUGH TO STAY IN. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15317454 ↗
  • MalfunctionFeb 11, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A FOREIGN BODY ON IT. DURING FOLLOW UP IT WAS REPORTED THAT THE FOREIGN MATERIAL LOOKED LIKE A FLECK ON THE IOL. THE ISSUE WAS NOTICED UPON IMPLANTATION. THE IOL WAS REMOVED AND REPLACED. ANOTHER IOL WAS SUCCESSFULLY IMPLANTED. IT IS NOT BELIEVED THAT THERE WAS ANY INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7262691 ↗
  • InjuryDec 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PCB00 32.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING GLARE AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available; Visual Disturbances

    MAUDE report 6137389 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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